Comparison of Three Different Prophylactic Treatments of PONV in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of PONV after tonsillectomy with or without adenoidectomy
研究概览
简要总结
Incidence of postoperative nausea and vomiting (PONV) in children after tonsillectomy with or without adenoidectomy may be as high as 75%.
Several medications may prevent and treat PONV, such as steroids, antidopaminergic drugs and serotonin (5-HT3) antagonists. The objective of this study is to compare three prophylactic antiemetic treatments:
- dexamethasone alone (250 mcg/kg)
- dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg)
- dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg).
详细描述
Tonsillectomy with or without adenoidectomy may be associated with severe postoperative nausea and vomiting (PONV). Causes are principally trigeminal nerve stimulation and presence of blood in the stomach. Consequences are disagreement, unsatisfactory, delayed discharge, and overnight admission in day-cases. More barely, patients may also have suture and esophagus rupture, aspiration of gastric contents, dehydration and electrolyte disturbances.
Several medications may prevent and treat PONV, such as steroids, antidopaminergic drugs and serotonin (5-HT3) antagonists. The objective of this study is to compare three prophylactic antiemetic treatments:
- dexamethasone alone (250 mcg/kg)
- dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg)
- dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg).
The hypothesis is that the combination of dexamethasone and droperidol is as effective as the combination of dexamethasone and ondansetron, both of them being more effective than dexamethasone alone. Moreover, droperidol is cheaper than ondansetron and may be recommended as a first-line treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged 2-10 y.
- •children ASA 1-2
- •weight > 15 kg
- •tonsillectomy with or without adenoidectomy
排除标准
- •intravenous induction
- •contraindication to steroids
- •contraindication to antidopaminergic drugs
- •contraindication to serotoninergic antagonists
- •administration of steroids, antidopaminergic drugs, or serotoninergic antagonists in the 24 hours before the surgery
- •refusal of parents
- •no-french speaking parents
研究组 & 干预措施
Dexamethasone
Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.
干预措施: Dexamethasone (Drug)
Dexamethasone and Droperidol
Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.
干预措施: Dexamethasone and droperidol (Drug)
Dexamethasone and Ondansetron
Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.
干预措施: Dexamethasone and Ondansetron (Drug)
结局指标
主要结局
Incidence of PONV after tonsillectomy with or without adenoidectomy
时间窗: 48 hours
次要结局
- Incidence of side effects (extrapyramidal syndrome, hemorrhage, somnolence, headaches)(48 hours)
研究者
Eric Albrecht
MD
Centre Hospitalier Universitaire Vaudois